Current partner codePEPTIDESDE
NCT07096726·Not applicable·INTERVENTIONAL

Boston Medical Center Ultrasound Decongestion Study in Heart Failure

Status

Not yet recruiting

Phase

Not applicable

Enrollment

200

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this study is to analyze the utility of a novel five-point ultrasound as a predictor of volume overload in diverse patients who are admitted with volume overload/congestive heart failure (CHF) exacerbation at Boston Medical Center (BMC), the largest safety-net hospital in New England. Current standard of care (SOC) involves the utilization of laboratory markers and physical exam, which is often inconsistent and equivocal. The investigators will assess will assess if ultrasound-assisted diuresis reduces recurrent episodes of volume overload/decompensated heart failure.

Full detailed description

This superiority randomized clinical trial will compare the therapeutic intervention of five-point ultrasound-guided diuresis with standard of care diuresis for decompensated heart failure. Participants with heart failure exacerbation will be randomly allocated in a 1:1 ratio using heart failure patient lists, by a heart failure physician in the emergency department or on the floors. Similarly, patients will be randomly selected in a 1:1 ratio in the outpatient heart failure infusion clinic when seen for heart failure exacerbation by a heart failure physician. The study population will be generally stable and can be inpatient or outpatient. The primary objective of the study is to evaluate and compare the efficacy of diuresis when driven by standard of care or five-point ultrasound to guide clinical decision making by assessing 30-day hospital readmission rate in patients undergoing standard of care vs ultrasound assisted diuresis. The specific aims are: Aim 1. To measure and compare changes in ultrasonographic parameters (ultrasound Doppler profiles, VExUS scores) through the course of a HF hospitalization for decongestion for acute decompensated HF admission. Aim 2. To compare 30-day and 90-day HF readmission rates between randomized patients with HF admission comparing SOC to VExUS-guided decongestion strategy. Aim 3: To compare worsening renal failure/acute renal injury (defined as 25% increase in serum Cr/cystatin C from time of admission to 4 weeks post-discharge) between randomized admitted HF patients comparing SOC to VExUS-guided decongestion strategy. Secondary objectives include: 1. To assess differences in diuretic responsiveness in individuals with varying cardiac dysfunction (i.e., length of stay for patients with HFpEF vs HFrEF) 2. To assess differences in diuretic responsiveness in individuals with varying right ventricular function 3. To assess differences in hospital length of stay between SOC and VExUS-guided decongestion groups 4. To assess differences in 30- and 90-day mortality between SOC and VExUS-guided decongestion groups 5. To assess differences in need for renal replacement therapy between SOC and VExUS-guided decongestion groups

Interventions

Treatment arms and agents.

DEVICE

Five-point ultrasound

In-person study visits will be done on initial evaluation and then at least every 48 hours, during which serial five-point ultrasound will be performed to assess venous congestion. Each visit will not be at strict intervals; a reasonable time window is every 48 hours +/- 12 hours. Ultrasound may be performed more frequently if clinically indicated. During these visits or between them, ultrasound of the heart may additionally be performed. Each visit will last between 10 and 60 minutes.

OTHER

Standard of care

Standard of care will most likely include radiographic investigations (chest X-ray, chest CT), laboratory evaluation (complete blood counts, metabolic panel, B-type natriuretic peptide, high-sensitivity troponin, electrolytes, renal function, urine testing), volume status, and cardiopulmonary physical exam.

Timeline

From registration to results.

  1. First posted

    Jul 31, 2025

  2. Study start

    Sep 2026

  3. Primary completion

    Dec 2027

  4. Study completion

    Dec 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 30, 2026

Outcomes

What the study measures.

Primary outcomes

VExUS Doppler profiles and scores

Time frame · At admission, At discharge (on average 3-10 days)

The range of VExUS profiles and scores to guide clinicians with heart failure diuresis are: No congestion (normal inferior vena cava), Minimal congestion (0 or 1 abnormal doppler patterns). Mild congestion (2 abnormal patterns and portal vein pulsatility fraction \[PVPF\] less than 30%), Moderate congestion (2 abnormal patterns and PVPF between 30 and 50%), Severe congestion (2 abnormal patterns and PVPF more than 50%).

30-day hospital readmission rate

Time frame · 30 days after discharge (on average 3-10 days)

The number of any hospital readmissions within 30 days of discharge will be abstracted from the participants' electronic medical records.

90-day hospital readmission rate

Time frame · 90 days after discharge (on average 3-10 days)

The number of any hospital readmissions within 90 days of discharge will be abstracted from the participants' electronic medical records.

Worsening renal failure/acute renal injury

Time frame · admission to 4 weeks post discharge (on average 3-10 days)

This outcome is defined by an increase in 25% of serum creatinine or serum cystatin C from the time of admission to 4 weeks post discharge. It will be abstracted from the participants' electronic medical records.

Secondary outcomes

Hospital length-of-stay for decompensated heart failure

Time frame · At hospital discharge (on average 3-10 days)

The total number of days hospitalized for decompensated heart failure will be abstracted from the participants' electronic medical records.

30-day HF readmission rate

Time frame · 30 days post discharge (on average 3-10 days)

The number of readmissions within 30-days of hospital discharge that are specifically due to HF

All-cause mortality

Time frame · 30 days, 90 days

All-cause mortality will be abstracted from the participants' electronic medical records.

Need for renal replacement therapy

Time frame · 30 days, 90 days

The need for renal replacement therapy will be abstracted from the participants' electronic medical records.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Patient with a primary diagnosis of acute on chronic decompensated heart failure who is admitted to inpatient or presents to the outpatient Boston Medical Center (BMC) Heart Failure Infusion clinic for decongestion treatment. * Willing and able to receive short abdominal and thoracic ultrasounds throughout hospitalization * Patients with right and/or left ventricular failure Exclusion Criteria: * Hemodynamic instability defined as systolic blood pressure \<85 mmHg or mean arterial pressure \<60 mm Hg for greater than 24 hours duration * Abdominal surgery in the past 1 month * Significant acute or chronic liver disease * End stage renal disease on dialysis * Advanced chronic kidney disease (CKD) \[Stage V CKD with glomerular filtration rate (GFR) \<15\] to exclude renal vein doppler ultrasound * Severe acute kidney injury (AKI) or requiring renal replacement therapy * Known abdominal thrombus in the inferior vena cava (IVC) or portal vein * Acute myocarditis * Acute valvular disease * Acute type 1 myocardial infarction * Medical condition precluding abdominal ultrasound due to significant discomfort or pain * Adults not able to provide consent (a simple teach back method of key aspects discussed in consent form will be utilized to verify if patient is able to adequately provide informed consent)

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Boston Medical Center

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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